Lung Cancer Nurse Model: a Phase II Study

NCT02362204 | Unknown

• 1 other identifier: UniversityFreiburg
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer patients experience significant physical symptoms, psychological distress and have many supportive care needs that impact on quality of life. Implementing the role of a Lung Cancer Nurse (LCN) is a response to meet the needs of patients and caregivers. Primary aim is to assess the feasibility of a LCN intervention and feasibility to collect longitudinal patient self-assessment questionnaires at the Thoracic Cancer Centre of the University Hospital of Lausanne. Secondary aims are: i) to describe self-reported changes in self-efficacy, symptoms and unmet supportive care needs across three time points during the first line therapy and ii) to explore professional acceptability of the new LCN model evaluating the perceptions of barriers and facilitators of the model by the LCN and the other multidisciplinary members of the comprehensive lung cancer care team. An exact single-stage (no interim analysis) design will be applied to determine feasibility for further studies to be undertaken. Secondary outcomes will be analyzed descriptively at each data collection (Baseline, Time1, Time2) time point and professional acceptability will be explored by focus groups with selected members of the interdisciplinary team.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility

  For a 5% probability of accepting a poor feasibility and a 20% probability of rejecting an acceptable feasibility we need to enroll 71 patients. Feasibility will be considered as acceptable for further studies if at least 36 patients reach the end of the study completing their scheduled Lung Cancer Nurse consultations and patients completed the three questionnaire at each data collect time (baseline, time 1 and time 2)

  11 weeks

Secondary Outcomes (3)

• Lung cancer symptoms

  Baseline-Week 3- Week 11

• Unmet Supportive Care Need

  Baseline-Week 3- Week 11

• Self-efficacy

  Baseline-Week 3- Week 11

Interventions

therapeutic education and psychological support BEHAVIORAL

Intervention consists of alternate face-to-face consultations (anticipated duration: 60-90 minutes) and telephone consultations (anticipated duration: 15-30 minutes). All interventions will include: i) a focused assessment of physical and psychological symptoms, ii) information about lung cancer (disease) and its treatment, iii) a review of disease-related and treatment-related side effects and strategies to manage these symptoms, and iv) printed listing and review of available support resources.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung cancer patients newly diagnosed receiving systemic therapy

You may qualify if:

• Patients newly diagnosed lung cancer (NSCLC or SCLC)
• Patients capable of speaking and writing in French
• Patients undergoing programmed a systemic treatment (with or without radiotherapy treatment)
• Estimated life expectancy more than 6-months
• Signing the written informed consent document

You may not qualify if:

• Patients diagnosed with lung cancer receiving only surgery treatment or only a radiotherapy treatment
• Patients not physically or emotionally capable of participating in the trial as determined by their oncologist (existing mental illness or severe physical disability)

Sponsors & Collaborators

• University of Freiburg: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

University Hospital of Lausanne

Lausanne, 1004, Switzerland

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Manuela Eicher, Dr

  University of Freiburg

  STUDY DIRECTOR

Central Study Contacts

Andrea Serena, MScN

CONTACT

0041 21 314 76 74; andrea.serena@hefr.ch

Manuela Eicher, Dr.

CONTACT

0041 26 429 60 55; manuela.eicher@hefr.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of research School of Health Sciences Fribourg-HEdS-FR

Study Record Dates

• First Submitted: February 7, 2015
• First Posted: February 12, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

CH (1)